Inspection Record

Home Intensive Care Pharmacy, LLC — FDA 483 Findings

US FDAInspected 2015-07-21Published 2024-01-17 8 findingsTraining and personnelDeviation, CAPA, and investigationAseptic processing and sterility assuranceStability and storageEquipment and facilityLaboratory and QC controls

Inspectors Latorie S. JonesThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Training and personnel

Clothing of personnel engaged in the processing of drug products is n ot appropriate for the duties they perform.

2Deviation, CAPA, and investigation

Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

4Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

5Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

6Equipment and facility

Routine calibration and checking of equipment is not performed according to a written program designed to assure proper performance.

7Laboratory and QC controls

Each batch of drug product purporting to be is not laboratory tested to determine conformance to such requirements.

8Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2015-07-21 · US FDA · 8 findings2015-07-11 · US FDA · 7 findings
Home Intensive Care Pharmacy, LLC company profile — full history US FDA documents, 2024 Go to Findings search